Details for New Drug Application (NDA): 200327
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NDA 200327 describes TEFLARO, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEFLARO profile page.
The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
The generic ingredient in TEFLARO is ceftaroline fosamil. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ceftaroline fosamil profile page.
Summary for 200327
| Tradename: | TEFLARO |
| Applicant: | Abbvie |
| Ingredient: | ceftaroline fosamil |
| Patents: | 2 |
Suppliers and Packaging for NDA: 200327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327 | NDA | Allergan, Inc. | 0456-0400 | 0456-0400-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) |
| TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327 | NDA | Allergan, Inc. | 0456-0600 | 0456-0600-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 400MG/VIAL | ||||
| Approval Date: | Oct 29, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,247,400 | Patent Expiration: | Feb 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
| Patent: | 9,629,861 | Patent Expiration: | Sep 21, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 600MG/VIAL | ||||
| Approval Date: | Oct 29, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,247,400 | Patent Expiration: | Feb 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING BACTERIAL INFECTIONS | ||||||||
Expired US Patents for NDA 200327
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-002 | Oct 29, 2010 | 7,419,973 | ⤷ Get Started Free |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-001 | Oct 29, 2010 | 6,417,175 | ⤷ Get Started Free |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-002 | Oct 29, 2010 | 6,417,175 | ⤷ Get Started Free |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-001 | Oct 29, 2010 | 7,419,973 | ⤷ Get Started Free |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-001 | Oct 29, 2010 | 6,906,055 | ⤷ Get Started Free |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327-002 | Oct 29, 2010 | 6,906,055 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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